FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
- Recall number
- Z-0611-2020
- Recalling firm
- Encore Medical, Lp
- Product
- EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
- Status
- Open, Classified
- Initiated
- 2019-02-04
- Posted
- 2019-12-06
- Terminated
- not on file
- Reason
- The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
- Root cause
- Device Design
- Action
- On February 4, 2019, DJO emailed consignees a Urgent Field Safety Notice" concerning the recalled product. This field safety notices provided consignees "best practices" for use of the device. On August 19, 2019, DJO revised their "Urgent Field Safety Notice" to communicate the exchange process for physical product in consignees inventory. The field safety notices asked consignees to take the following actions: 1. Please locate within your inventory part 800-05-035 in FA K EMP COMP PAT TOOL KIT, FA K EMP PAT TOOL KIT, and FA K EMP PAT TOOL KIT WIMPCTR. The quantities shown within each consignee letter is specific to the consignee. 2. Contact Customer Service to initiate a return of the product via RMA and to have the replacement impactors sent to you. 3. If you have any questions, please contact Teffany Hutto by phone at (512) 834-6255 or by email at teffany.hutto@djoglobal.com.
- Quantity
- 410 devices
- Distribution
- CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY OUS: None
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28